Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial (LIFUS)

Mass General Brigham

Status

Enrolling

Conditions

Drug Resistant Epilepsy

Treatments

Device: Focused ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03868293

2018P000125

Details and patient eligibility

About

The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.

Full description

The aim of the proposed pilot study is to investigate safety and tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.

Due to the lack of options for patients with drug-resistant epilepsy, investigations into alternative noninvasive treatments are warranted. PLIFUS has been shown to safely modulate neuronal tissue, and is non-invasive and painless. Several human studies have shown that the use of PLIFUS can suppress somatosensory evoked potentials and induce functional magnetic resonance imaging (MRI) responses.

Once the subject is enrolled in the study, the subject will be scheduled for a standard brain MRI scan at BWH if they have not had one in the last 3 months. The subject will be asked to keep track of their seizure events in the Daily Seizure Log Diary from the screening visit until 6 months after the last treatment session.

The treatment period will include 6 treatment sessions total. These will occur 2 days per week for 3 weeks, each lasting approximately 1-2 hours, starting 1 month after seizure logging begins.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects at least eighteen (18) years of age
Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.
Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency
Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.

Exclusion criteria

Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
Subjects with ferromagnetic materials in the head
Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
Subjects who have primary generalized epilepsy or non-epileptic seizures
Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study
Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
Subjects with current brain tumors or an intracranial vascular lesion
Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
Subjects with holes in the treatment area of the skull from trauma or prior surgery
Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.